MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 3MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035453080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil delivery wire was seen to be kinked/bent.There was dried blood seen within the sheath.The coil delivery wire was seen to be broken fractured.The device would not advance through the sheath.Upon retracting the device out of the sheath the coil stretched and detached during analysis.A functional test determine that he device was flushed but could not be advanced in the introducer sheath and the device had to be retracted out of the sheath.The coil introducer sheath fails.The reported event could not be confirmed; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The coil delivery wire was kinked bent and broken.And, the coil was causing friction in the introducer sheath.The as reported can be confirmed.The as reported, coil in catheter friction as well as the as analyzed, coil introducer sheath friction will be assigned procedural factors as it appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.The as analyzed, coil delivery wire kinked bent and coil delivery wire broken/fractured during use will be assigned handling damage as it appears to be associated with handling of the product or portion of the product during the procedure.
Event or Problem Description
It was initially reported that during the embolism of pcoma aneurysm, a guide wire and microcatheter were used to delivered the a coil (subject device) to target site.However, the subject coil experienced friction at the proximal of the microcatheter and could not be advanced out of the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.Analysis of the returned device found that the coil delivery wire (subject device) was found broken/fracture during use.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TARGET HELICAL NANO 3MM X 8CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 12278018
• Report Number: 3008881809-2021-00323
• Device Sequence Number: 4742034
• Product Code: HCG
• UDI-Device Identifier: 07613252600442
• UDI-Public: 07613252600442
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2023
• Device Model Number: M0035453080
• Device Catalogue Number: M0035453080
• Device Lot Number: 22606516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR